Abstract

Introduction

The treatment of inflammatory bowel disease (IBD) with anti-tumour necrosis factor (anti-TNF) biologic therapies such as infliximab is expensive, due to the complex development and manufacturing processes involved with the drug. The number of paediatric patients (PP) receiving infliximab at our trust is increasing, leading to NHS cost pressures. The patent for the infliximab reference molecule Remicade has expired and considerably cheaper biosimilar products are now available, such as Remsima. The license for Remsima was based on adult rheumatology patients; this data was then extrapolated across all licenses. There are currently no long term safety studies of Remsima in children.

Introduction

A biosimilar drug can be defined as ‘a biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.’1

Aim

We wanted to switch all PP receiving infliximab for IBD at our trust from Remicade to a new biosimilar product – Remsima.

Method

The paediatric gastroenterology MDT agreed that all new patients started on infliximab since spring 2016 would be treated with Remsima.

Method

Information was gathered regarding the safety, switchability and efficacy of Remsima before the change was made.2 For existing patients, we also contacted other trusts who had already made the switch to gain from their experience. Our current patients on Remsima were reviewed, and no problems were reported.

Method

Existing patients were identified and a letter informing their parent/guardian of why we were changing from Remicade to Remsima was posted. An agreed date after which the switch in treatment would occur allowed any concerns or questions to be addressed on previous visits to the hospital.

Results

Overall, the method used was a success: all but one of the identified patients agreed to switch to Remsima – one family refused and the child continues to receive Remicade treatment. All patients on Remsima continue to be monitored closely for adverse reactions or a decline in their disease control. Infliximab levels and antibodies are checked as per local guidelines. Any adverse reactions are reported to the MHRA via the yellow card scheme; Remsima is a black triangle medicine.3

Conclusion

Biosimilar medicines present a considerable cost saving to the NHS, and by switching our paediatric IBD patients receiving treatment with infliximab from the reference molecule Remicade to the biosimilar Remsima, the Trust has been able to take advantage of this.

Conclusion

The saving is substantial and across our 60+patients is somewhere in the region of £250,000 – £2 75 000 a year. This money can be reinvested into the paediatric IBD service to improve patient care. We hope that our experience of switching can be used to support other Trusts in following suit.

Conclusion

As further biosimilar medications become available, the NHS could continue to benefit by switching patients receiving biologic treatment.